Dosage Form: injection, solution, concentrate
M.V.I. − 12®
Pharmacy Bulk Package
(Multi-Vitamin Infusion without vitamin K)
For dilution in intravenous infusions only.
Rx only
Multi Vitamin Infusion M.V.I. 12 Description
M.V.I.−12® is available as a sterile product consisting of two vials, labeled Vial 1 (50 mL) and Vial 2 (50 mL Fill) to provide ten 10 mL single doses.
Adult Formulation (intended for ages 11 and older)
Vial 1* | |
Ingredient | Amount per Unit Dose |
Fat Soluble Vitamins** | |
Vitamin A (retinol) | 1 mga |
Vitamin D (ergocalciferol) | 5 mcgb |
Vitamin E (dl-alpha-tocopheryl acetate) | 10 mgc |
Water Soluble Vitamins | |
Vitamin C (ascorbic acid) | 200 mg |
Niacinamide | 40 mg |
Vitamin B2 (as riboflavin 5-phosphate sodium) | 3.6 mg |
Vitamin B1 (thiamine) | 6 mg |
Vitamin B6 (pyridoxine HCl) | 6 mg |
Dexpanthenol (d-pantothenyl alcohol) | 15 mg |
*WITH 30% PROPYLENE GLYCOL AND 2% GENTISIC ACID ETHANOLAMIDE AS STABILIZERS AND PRESERVATIVES; SODIUM HYDROXIDE FOR PH ADJUSTMENT; 1.6% POLYSORBATE 80; 0.028% POLYSORBATE 20; 0.002% BUTYLATED HYDROXYTOLUENE; 0.0005% BUTYLATED HYDROXYANISOLE. **Fat-soluble vitamins A, D, and E are water solubilized with polysorbate 80. (a) 1 mg vitamin A equals 3,300 USP units. (b) 5 mcg ergocalciferol equals 200 USP units. (c) 10 mg vitamin E equals 10 USP units. | |
Vial 2* | |
Biotin | 60 mcg |
Folic acid | 600 mcg |
Vitamin B12 (cyanocobalamin) | 5 mcg |
*WITH 30% PROPYLENE GLYCOL; AND CITRIC ACID, SODIUM CITRATE, AND SODIUM HYDROXIDE FOR PH ADJUSTMENT. | |
“Aqueous” multivitamin formula for intravenous infusion: M.V.I.−12® (Multi-Vitamin Infusion without vitamin K) makes available a combination of important fat-soluble and water-soluble vitamins in an aqueous solution, formulated specially for incorporation into intravenous infusions. Through special processing techniques, the liposoluble vitamins A, D, and E have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.
Indications and Usage for Multi Vitamin Infusion M.V.I. 12
This formulation is indicated for the prevention of vitamin deficiency and thromboembolic complications in people receiving home parenteral nutrition who also receive warfarin-type anticoagulant therapy.
The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.
Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days as indicated by the clinical status. Clinical testing indicates that some patients do not maintain adequate levels of certain vitamins when this formulation in recommended amounts is the sole source of vitamins.
Contraindications
Known hypersensitivity to any of the vitamins in this product or a pre-existing hypervitaminosis. Allergic reaction has been known to occur following intravenous administration of thiamine. This formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits.
Warnings
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phospate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Precautions
Studies have shown that vitamin A may adhere to plastic, resulting in inadequate vitamin A administration in the doses recommended with M.V.I.−12®.
Where long-standing specific vitamin deficiencies exist, it may be necessary to add therapeutic amounts of specific vitamins to supplement the maintenance vitamins provided in M.V.I.−12®.
In patients receiving parenteral multivitamins, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing.
M.V.I.−12® SHOULD BE ASEPTICALLY TRANSFERRED TO THE INFUSION FLUID.
Drug-Drug Interactions:
Physical Incompatibilities:
M.V.I.−12® (Multi-Vitamin Infusion without vitamin K) is not physically compatible with DIAMOX® (acetazolamide) 500 mg, DIURIL® Intravenous Sodium (chlorothiazide sodium) 500 mg, or aminophylline 125 mg, ampicillin 500 mg or moderately alkaline solutions. ACHROMYCIN® (tetracycline HCl) 500 mg may not be physically compatible with M.V.I.−12®. It has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Some of the vitamins in M.V.I.−12® may react with vitamin K bisulfite. Direct addition of M.V.I.−12® to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided.
Several vitamins have been reported to decrease the activity of certain antibiotics. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin.
Some of the vitamins in M.V.I.−12® may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies.
Clinical Interactions:
A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions.
Folic acid may lower the serum concentration of phenytoin resulting in increased seizure frequency. Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy. Folic acid may decrease the patient’s response to methotrexate therapy.
Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism. Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements.
In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol.
Consult appropriate references for additional specific vitamin-drug interactions.
Drug-Laboratory Test Interactions
ASCORBIC ACID IN THE URINE MAY CAUSE FALSE NEGATIVE URINE GLUCOSE DETERMINATIONS.
Carcinogenesis, Mutagenesis, and Impairment of Fertility:
Carcinogenicity studies have not been performed.
Pregnancy:
Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women.
Nursing Mothers:
Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonlactating women.
Pediatric Use:
Safety and effectiveness in children below the age of 11 years have not been established.
Adverse Reactions
There have been rare reports of anaphylactoid reactions following large intravenous doses of thiamine. The risk, however, is negligible if thiamine is co-administered with other vitamins in the B group. There have been no reports of fatal anaphylactoid reactions associated with M.V.I.−12®.
There have been rare reports of the following types of reactions:
Dermatologic — rash, erythema, pruritus
CNS — headache, dizziness, agitation, anxiety
Ophthalmic — diplopia
Allergic — urticaria, periorbital and digital edema
Overdosage
The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1.5 mg/day retinol. Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution.
Multi Vitamin Infusion M.V.I. 12 Dosage and Administration
M.V.I.−12® is ready for immediate use in adults and children aged 11 years and above when added to intravenous infusion fluids.
Directions for Pharmacy Bulk Package:
Transfer the contents of Vial 1 into Vial 2. The mixed solution will provide ten 10 mL single doses. Each 10 mL single dose is ready for dilution in not less than 500 mL of infusion fluid. Utilize a suitable sterile transfer device or dispensing set, which allows measured distribution of the contents.
The withdrawal of container contents should be accomplished without delay. The solution should be used within 4 hours after dilution.
USE OF THIS PRODUCT IS RESTRICTED TO A SUITABLE WORK AREA, SUCH AS A LAMINAR FLOW HOOD.
M.V.I.−12® should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation.
FOR INTRAVENOUS FEEDING, ONE DAILY DOSE OF M.V.I.−12® (10 ML) ADDED DIRECTLY TO NOT LESS THAN 500 ML, PREFERABLY 1,000 ML, OF INTRAVENOUS DEXTROSE, SALINE OR SIMILAR INFUSION SOLUTIONS.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
After M.V.I.−12® is diluted in an intravenous infusion, the resulting solution is ready for immediate use. Some of the vitamins in this product, particularly A and D and riboflavin, are light sensitive, and exposure to light should be minimized.
Store at 2-8°C (36-46°F).
How is Multi Vitamin Infusion M.V.I. 12 Supplied
M.V.I.-12® PHARMACY BULK PACKAGE — NDC 61703-423-83. 2 boxes of 10 vials, 50 mL each (5 Vial 1 and 5 Vial 2). Mix contents of Vial 1 and Vial 2 to provide ten single doses.
Created: February, 2009
| Printed in USA | EN-2050 |
Hospira, Inc., Lake Forest, IL 60045 USA | |
CA-2074
| MULTI VITAMIN INFUSION retinol, ergocalciferol, ascorbic acid, niacinamide, thiamine, biotin, folic acid, cyanocobalamin, vitamin e, pyridoxine hydrochloride, and dexpanthenol injection, solution, concentrate | ||||||||||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA008809 | 06/08/2010 | |
| Labeler - Hospira Worldwide, Inc. (141588017) |
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